[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-gliomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-gliomas":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100586048","alpha-radiation-emitters-device-dart-for-the-treatment-of-recurrent-glioblastoma-100586048",false,"NCT06910306","Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma","A Study to Assess the Feasibility and Safety of Intratumoral Diffusing Alpha Emitters for the Treatment of Recurrent Glioblastoma","Inclusion Criteria:\n\n* Males and females ≥ 18 and ≤ 85 years of age\n* Patients must have histologically confirmed diagnosis of WHO grade IV glioblastoma (including variants such as gliosarcoma, giant cell glioblastoma).\n* Single, gadolinium-enhancing tumor recurrence ≤ 3cm in maximum diameter\n* Patient not amenable for surgical resection due to any of the following but not limited reasons: patient refusal, medically ineligible, surgically too high risk due to tumor location in a deep and\u002For eloquent location.\n* Prior history of central nervous system (CNS) radiation (standard dose) with 50.4-60 Gy delivered in 1.8 Gy-2.0 Gy fractions with concurrent temozolomide (if the patient has received a non-standard fractionation or radiation dose, such as 40 Gy in 15 fractions.\n* Patients must have a time interval ≥4 months between completion of prior radiation and trial registration and have tumor progression per RANO criteria\n* Patients must have a measurable disease per RANO criteria\n* Estimated life expectancy is more than 6 months\n* Target lesion amenable for coverage by the DaRT sources\n* Patient must either have had recent subtotal surgery\u002Fbiopsy following tumor recurrence (at least 6 weeks from trial registration) or must have shown unequivocal radiographic evidence for tumor progression by contrast-enhanced MRI scan within 21 days prior to trial registration. If surgery was performed, must have a post-operative MRI scan within 21 days prior to trial registration.\n* Patients have recovered from prior therapy side effects and must be at least 4 weeks post administration of chemotherapies or investigational agents with the exception of nitrosureas (such as Carmustine, Fotemustine, Lomustine) which requires 42 days of washout.\n* Karnofsky performance score (KPS) of at least 60 documented within 14 days prior to trial registration\n* Patients must have adequate biological parameters as demonstrated by the following blood counts at initial screening obtained ≤ 14 days prior to starting treatment Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL Platelet count ≥ 100,000\u002Fmm3 (80 × 109\u002FL) Hemoglobin (Hgb) ≥ 9 g\u002FdL.\n* Patients must have the following blood chemistry levels at initial screening obtained ≤ 14 days prior to starting treatment AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN) Total bilirubin ≤ 1.5 × ULN\n* Effective contraception must be used by both male and female patients while on the study and for up to 3 months following treatment\n* Patient must have been informed about the nature of the study, and must have agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities\n\nExclusion Criteria:\n\n* Medical contraindication to MRI (cardiac devices are allowed if MRI compatible)\n* More than 3 relapses per RANO criteria\n* Acquired and or genetic clinical bleeding tendency\n* Suspicious of infratentorial or leptomeningeal or intraventricular disease\n* Concomitant chemotherapy or any other systemic therapy not allowed in the protocol\n* Recent or current (within 6 weeks) therapy with VEF or a VEGFR inhibitor\n* Immunocompromised state due to either transplant or AIDS\n* Prior allergic reaction to the study drugs\n* History of hypertensive crisis or hypertensive encephalopathy\n* Uncontrolled hypertension (defined as either \\>150 mm\u002FHg for systolic and \\>90mm\u002FHg for diastolic)\n* History of a non-healing wound, ulcer, gastrointestinal bleed (\\> grade 3), traumatic injury, or bone fracture within 90 days prior to registration Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT\n* High probability of protocol non-compliance (in opinion of investigator)\n* Pregnancy or lactation\n* Collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis","ALL","18 Years","85 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of recurrent Glioblastoma",[27,28],"Recurrent Glioblastoma","Recurrent Gliomas",[27,30,31,32,33],"Brachytherapy","GBM","Alpha DaRT sources","Intratumoral Diffusing Alpha Emitters","RECRUITING","2026-06-15",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":38},"2025-10-01",{"date":42,"type":21},"2026-12-01",{"name":44,"class":45},"Alpha Tau Medical LTD.","INDUSTRY",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100629060","vorasidenib-guided-by-agx-pet-in-recurrentlow-grade-glioma-100629060","NCT07469735","Vorasidenib Guided by AGX PET in Recurrent\u002FLow-grade Glioma","18F-AGX PET for Evaluation of Vorasidenib Response and Tumor Metabolic Changes in Low-grade IDH-Mutant Glioma","VANGUARD","Inclusion Criteria:\n\n1. Histologically or molecularly confirmed WHO 2021 grade 2 or 3 IDH1\u002F2-mutant diffuse glioma with recurrent or residual disease\n2. At least one measurable non-enhancing lesion (≥1 cm × ≥1 cm) on postoperative T2\u002FFLAIR MRI\n3. Eligible for Vorasidenib treatment\n4. Age ≥18 years\n5. Karnofsky Performance Status (KPS) score ≥80\n6. Adequate hematologic function\n7. Adequate renal function\n8. Adequate hepatic function\n9. Ability to provide written informed consent\n\nExclusion Criteria:\n\n1. Prior treatment with radiotherapy, chemotherapy, or IDH inhibitors\n2. Known contraindications to Vorasidenib\n3. Contraindications to PET\u002FCT imaging\n4. Uncontrolled hyperglycemia\n5. Pregnancy or breastfeeding\n6. Inability to undergo repeated intravenous injections\n7. Known hypersensitivity to imaging agents or study-related medications\n8. Use of strong CYP1A2 inhibitors or CYP2C19 or CYP3A substrates with narrow therapeutic index\n9. Any serious comorbid condition that may interfere with study participation or safety",{"count":20,"type":21},[24],"The goal of this prospective, single-arm, open-label clinical trial is to evaluate whether 18F-AGX PET imaging can be used to assess early treatment response and metabolic changes in adult patients with recurrent or residual WHO 2021 grade 2-3 IDH-mutant diffuse glioma receiving Vorasidenib therapy.\n\nIDH-mutant diffuse gliomas often show slow tumor growth, making early treatment response difficult to evaluate using conventional structural imaging such as magnetic resonance imaging (MRI). Clinical endpoints such as progression-free survival (PFS) and overall survival (OS) typically require long follow-up periods to detect treatment effects. Therefore, the development of sensitive and noninvasive imaging methods for early evaluation of therapeutic response is needed.\n\nThis study aims to determine whether metabolic changes detected by 18F-AGX PET during Vorasidenib treatment are associated with tumor structural changes and clinical outcomes.\n\nThe main questions it aims to answer are:\n\n* Whether early changes in tumor metabolic activity measured by 18F-AGX PET, including percentage change in maximum tumor-to-background ratio (TBRmax), are associated with changes in tumor growth rate (TGR) measured by MRI during treatment.\n* Whether early metabolic response detected by 18F-AGX PET imaging after initiation of Vorasidenib treatment can predict subsequent disease progression or tumor growth dynamics.\n\nParticipants enrolled in this study will receive oral Vorasidenib once daily for 12 treatment cycles (28 days per cycle), with dosing based on body weight.\n\nParticipants will:\n\n* Undergo baseline MRI and 18F-AGX PET imaging following surgery for recurrent or residual disease.\n* Receive oral Vorasidenib continuously for 12 cycles.\n* Undergo MRI scans at baseline and during treatment cycles 1, 2, 3, 6, 9, and 12 to assess structural tumor changes.\n* Undergo 18F-AGX PET\u002FCT scans at baseline and during treatment cycles 1, 2, 3, 6, and 12 to assess metabolic tumor activity.\n* Provide serial blood samples for laboratory safety monitoring, including hematologic and biochemical testing.\n* Undergo magnetic resonance spectroscopy (MRS) to quantify intratumoral 2-hydroxyglutarate (2-HG) levels as an indicator of IDH mutation-associated metabolic activity.\n\nParticipants will be followed for imaging-based disease progression using RANO criteria and for treatment-related adverse events during the study period.\n\nThis study will evaluate the feasibility of using 18F-AGX PET imaging as a noninvasive imaging biomarker for early response assessment in IDH-mutant diffuse glioma patients receiving targeted IDH inhibition therapy with Vorasidenib.",[59,60,28],"Glioma","Diffuse Glioma",[62,63,64,65],"IDH Mutation","Vorasidenib","Positron Emission Tomography","Treatment Response","NOT_YET_RECRUITING","2026-03-09",{"date":69,"type":38},"2026-03-13",{"date":71,"type":21},"2026-04-01",{"date":73,"type":21},"2027-12-31",{"name":75,"class":76},"Huashan Hospital","OTHER",1]